Achieving With Confidence In Patients with ALGS - European Medical Journal

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Achieving With Confidence In Patients with ALGS

Hepatology

This promotional communication is funded and organised by Ipsen, for healthcare professionals only.

▼KAYFANDA odevixibat prescribing information can be found here.

Adverse events reporting information can be found at the bottom of the page.

▼ This medicinal product is subject to additional monitoring.

KAYFANDA is now indicated for the treatment of cholestatic pruritus in patients with Alagille Syndrome (ALGS) aged 6 months or older1

ALGS is a rare, complex, life-threatening, multisystem, genetic disease2.
Ipsen is proud to be launching KAYFANDA® (odevixibat) to support patients with ALGS.

KAYFANDA is the first and only ileal bile acid transporter inhibitor (IBATi) to be tested in a robust Phase III clinical trial program in ALGS1,3,4

Reduced pruritus3,4
91% of patients achieved a meaningful reduction in pruritus defined by ≥1-point change at any time point over 24 weeks3

Reduced serum bile acids3,4
Serum bile acid (sBA) reductions were early, rapid and sustained3,4

Reduced tiredness3,4

KAYFANDA is the only IBATi to demonstrate impact on sleep independent of pruritus in ALGS1,3-5


Well-established tolerability profile1,3
Low, mild and generally transient gastrointestinal adverse events with no concerns associated with propylene glycol1

Simple and flexible dosing1
A simple, once daily formulation.1 Capsules can be swallowed whole, or opened to mix pellets with liquid or soft food.1

 

KAYFANDA is a selective and potent IBATi* for ALGS1

Watch the video below to discover the mode of action of odevixibat.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions to [email protected] and via the national reporting system as described in section 4.8 of the product prescribing information.

 

References:

  1. Ipsen Kayfanda (odevixibat). EMA Summary of product characteristics. 2024. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/kayfanda. Last accessed 10 December 2024.
  2. Kamath BM et al. Systematic Review: The Epidemiology, Natural History, and Burden of Alagille Syndrome. J Pediatr Gastroenterol Nutr. 2018;67(2):148-56.
  3. Ovchinsky N et al. Efficacy and safety of odevixibat in patients with Alagille syndrome (ASSERT): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2024;9(7):632-45.
  4. Ovchinsky N, et al. Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome: Interim Results From the Open-Label Phase 3 ASSERT-EXT Study. European Society for Paediatric Gatroenterology, Hepatology and Nutrition (ESPGHAN) Annual Meeting, 17-20 May, 2023.
  5. Ipsen Kayfanda (odevixibat). EMA Prescribing Information. 2024. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/kayfanda. Last accessed 10 December 2024.

 

KAY-ALL-000015 December 2024

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